Presbyopia
Conditions
Brief summary
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Detailed description
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
Interventions
DRUGBRIMOCHOL™ PF
A single drop in each eye at a visit.
DRUGCarbachol PF
A single drop in each eye at a visit.
A single drop in each eye at a visit.
Sponsors
Visus Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female in good general health * Must have presbyopia
Exclusion criteria
* History of allergic reaction to the study drug or any of its components * Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | Day 1 Hour 1 | Primary endpoint measure at hour 1 post-dose at study visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects 3 study treatments across 4 study visits | 182 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| First Washout | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
| First Washout | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 1 |
| Second Washout | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Second Washout | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 |
| Visit 2 First Intervention | Randomization error | 0 | 0 | 0 | 1 | 0 | 0 |
| Visit 3 Second Intervention | Inclusion Criteria | 1 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 55 Years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 135 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 116 Participants |
| Region of Enrollment United States | 182 Participants |
| Sex: Female, Male Female | 113 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 178 | 0 / 177 | 0 / 176 |
| other Total, other adverse events | 37 / 178 | 24 / 177 | 2 / 176 |
| serious Total, serious adverse events | 1 / 178 | 0 / 177 | 0 / 176 |
Outcome results
Primary
Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity
Primary endpoint measure at hour 1 post-dose at study visit
Time frame: Day 1 Hour 1
Population: All participants who received at least one dose of study treatment (mITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BRIMOCHOL™ PF | Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | 49.4 Percentage of participants |
| Carbachol PF | Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | 35.0 Percentage of participants |
| Brimonidine Tartrate | Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | 22.7 Percentage of participants |
p-value: <0.001Regression, Logistic